This study is a prospective, investigator-initiated, multi-center, single arm, observational registry of performance of Excimer Laser Coronary Atherectomy (ELCA) in standard use cases of percutaneous coronary intervention (PCI).
The total study duration is 3 years, including 2 years of recruitment.
ClinicalTrials.gov ID: NCT07348341
Sponsor
Sponsored by Supported by
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Study objectives
The primary objective of the CLARIT study is to assess the Safety and Efficacy of ELCA in recognized indications for the device at Index PCI and during the in-hospital stay. The secondary objectives includes the safety and efficacy of ELCA at 30 days and 1 year, as well as the procedural characteristics for the assessment of the learning curve and impact on the catheter lab workflow.
Countries
8 countries in Europe, United Kingdom and India
Number of investigational sites
20
Number of patients
500 patients will be included
The patients included in the study according to eligibility criteria will be followed up one year.
